FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
1705–1728 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 24, 2010
BASESENS BLOOD GLUCOSE MONITORING SYSTEM
K093475 · NBW
Hygeia, Inc.
Chemistry · 110d
Cleared Feb 24, 2010
EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM
K092894 · NBW
Eps Bio Technology Corp.
Chemistry · 156d
Cleared Feb 19, 2010
INTOUCH DIABETES
K093789 · NBW
Symcare Personalized Health...
Chemistry · 72d
Cleared Feb 19, 2010
FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING...
K093712 · NBW
Taidoc Technology Corporation
Chemistry · 79d
Cleared Feb 19, 2010
ACCELERATOR APS
K093318 · CEM
Abbott Laboratories
Chemistry · 119d
Cleared Feb 18, 2010
MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS
K093635 · NBW
Taidoc Technology Corporation
Chemistry · 87d
Cleared Feb 12, 2010
B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644
K093631 · CDD
Siemens Healthcare Diagnostics
Chemistry · 80d
Cleared Feb 05, 2010
FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING...
K093005 · NBW
Taidoc Technology Corporation
Chemistry · 130d
Cleared Feb 04, 2010
ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS...
K092649 · NBC
Roche Diagnostics Corp.
Chemistry · 160d
Cleared Feb 04, 2010
OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM
K090609 · NBW
Ok Biotech Co., Ltd.
Chemistry · 335d
Cleared Feb 03, 2010
AMPHETAMINES II
K083764 · DKZ
Roche Diagnostics Corp.
Chemistry · 412d
Cleared Jan 19, 2010
EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM
K091765 · NBW
Visgeneer, Inc.
Chemistry · 216d
Cleared Jan 15, 2010
NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS...
K091547 · NBW
Nova Biomedical Corp.
Chemistry · 233d
Cleared Jan 14, 2010
ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE...
K091867 · CDZ
Siemens Healthcare Diagnostics
Chemistry · 205d
Cleared Jan 14, 2010
CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL...
K082275 · LCP
Infopia Co, Ltd.
Chemistry · 521d
Cleared Dec 24, 2009
FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244
K093035 · NBW
Taidoc Technology Corporation
Chemistry · 85d
Cleared Dec 23, 2009
AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM
K093098 · KQO
Arkray, Inc.
Chemistry · 83d
Cleared Dec 16, 2009
ELECSYS PROBNP II CALCHECK 5
K092169 · JJX
Roche Diagnostics
Chemistry · 148d
Cleared Dec 14, 2009
LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913
K093498 · JJX
DiaSorin, Inc.
Chemistry · 32d
Cleared Dec 14, 2009
SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
K090940 · JJT
Astoria-Pacific, Inc.
Chemistry · 255d
Cleared Dec 11, 2009
S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023
K091711 · LCP
Alfa Wassermann Diagnostic...
Chemistry · 184d
Cleared Dec 10, 2009
NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253...
K092099 · NBW
Taidoc Technology Corporation
Chemistry · 149d
Cleared Dec 08, 2009
SD CHECK GOLD
K082683 · NBW
Standard Diagnostics, Inc.
Chemistry · 449d
Cleared Dec 07, 2009
DS-A BLOOD GLUCOSE MONITORING SYSTEM
K082965 · CGA
Alliance International Co., Ltd.
Chemistry · 430d